ID

13264

Description

Study part: Visit V4 (Day 84 + - 7). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

Keywords

  1. 1/28/16 1/28/16 -
Uploaded on

January 28, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Visit V4_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79

Visit V4 (Day 84 + - 7)

Visit 4
Description

Visit 4

Alias
UMLS CUI-1
C0545082
Date of visit
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Does the patient still take part in the study?
Description

Study Subject Participation Status

Data type

text

Alias
UMLS CUI [1]
C2348568
Did the patient take the medication according to the protocol?
Description

compliance

Data type

text

Alias
UMLS CUI [1]
C1321605
If the compliance was not always, please mention in detail
Description

details compliance

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1321605
Comorbidity? Please fill up the form "Documentation adverse event"
Description

Comorbidity

Data type

boolean

Concomitant medication? Please use the form "Documentation Concomitant medication"
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Date for next visit 5 (Day 140 + - 7 days)
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Did an adverse event occur during the treatment? (If yes, please use the form "Documentation adverse event")
Description

adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Did a serious adverse event occur during the treatment? (If yes, please use the form "Documentation serious adverse events")
Description

serious adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Are there any undocumented adverse events, which were not recorded during the previous visit? (If yes, please use the form "Documentation adverse event")
Description

adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Description

systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

heart rate

Data type

integer

Measurement units
  • 1/ min
Alias
UMLS CUI [1]
C0018810
1/ min
Examination (Rhinoscope)
Description

Examination (Rhinoscope)

Alias
UMLS CUI-1
C0582103
UMLS CUI-2
C0183044
Edema
Description

edema

Data type

text

Alias
UMLS CUI [1]
C0013604
Secretion
Description

Secretion, Nasal

Data type

text

Alias
UMLS CUI [1]
C1546724
Redness
Description

Redness

Data type

text

Alias
UMLS CUI [1]
C0332575
Spirometry or Peak expiratory flow measurement (For asthmatics)
Description

Spirometry or Peak expiratory flow measurement (For asthmatics)

Alias
UMLS CUI-1
C0037981
UMLS CUI-3
C0521299
FEV1 (age-appropriate standard value)
Description

FEV1

Data type

float

Alias
UMLS CUI [1]
C0748133
FEV1
Description

FEV1

Data type

float

Alias
UMLS CUI [1]
C0748133
FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
Description

Ratio; FEV1; standard value

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0456603
UMLS CUI [2]
C0588029
UMLS CUI [3]
C1442989
%
PEF 1
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
PEF 2
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
PEF 3
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Best PEF
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Study medication and Concomitant medication (Taking back of the second study medication box with 7 blister pack)
Description

Study medication and Concomitant medication (Taking back of the second study medication box with 7 blister pack)

Alias
UMLS CUI-1
C0013227
Number of tablets left (study medication)
Description

medication study

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0008972
Number of tablets left (Loratadin)
Description

medication Demand

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0441516
Mention, if incomplete
Description

details

Data type

text

Alias
UMLS CUI [1]
C1522508
Handing out of third study medication box with 8 blister pack and 1 blister pack of concomitant medication (if necessary)
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Conjunctival provocation testing
Description

Conjunctival provocation testing

Alias
UMLS CUI-1
C0430565
Conjunctival provocation test result 1
Description

Conjunctival provocation testing

Data type

text

Alias
UMLS CUI [1]
C0430565
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
Description

Conjunctival provocation testing

Data type

text

Alias
UMLS CUI [1]
C0430565
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
Description

Conjunctival provocation testing

Data type

text

Alias
UMLS CUI [1]
C0430565
Allergen concentration at which the test outcome is positive
Description

concentration allergen

Data type

text

Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0002092
The outcome for all tests is negative
Description

Conjunctival provocation testing

Data type

boolean

Similar models

Visit V4 (Day 84 + - 7)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit 4
C0545082 (UMLS CUI-1)
date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Item
Does the patient still take part in the study?
text
C2348568 (UMLS CUI [1])
Code List
Does the patient still take part in the study?
CL Item
yes (1)
CL Item
no, please then fill up the form "Study completion" (2)
Item
Did the patient take the medication according to the protocol?
text
C1321605 (UMLS CUI [1])
Code List
Did the patient take the medication according to the protocol?
CL Item
always (1)
CL Item
mostly yes (2)
CL Item
mostly no (3)
CL Item
no (4)
details compliance
Item
If the compliance was not always, please mention in detail
text
C0392360 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Comorbidity
Item
Comorbidity? Please fill up the form "Documentation adverse event"
boolean
Concomitant medication
Item
Concomitant medication? Please use the form "Documentation Concomitant medication"
boolean
C2347852 (UMLS CUI [1])
Date
Item
Date for next visit 5 (Day 140 + - 7 days)
date
C0011008 (UMLS CUI [1])
adverse event
Item
Did an adverse event occur during the treatment? (If yes, please use the form "Documentation adverse event")
boolean
C0877248 (UMLS CUI [1])
serious adverse event
Item
Did a serious adverse event occur during the treatment? (If yes, please use the form "Documentation serious adverse events")
boolean
C1519255 (UMLS CUI [1])
adverse event
Item
Are there any undocumented adverse events, which were not recorded during the previous visit? (If yes, please use the form "Documentation adverse event")
boolean
C0877248 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Examination (Rhinoscope)
C0582103 (UMLS CUI-1)
C0183044 (UMLS CUI-2)
Item
Edema
text
C0013604 (UMLS CUI [1])
Code List
Edema
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
Item
Secretion
text
C1546724 (UMLS CUI [1])
Code List
Secretion
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
Item
Redness
text
C0332575 (UMLS CUI [1])
Code List
Redness
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
Item Group
Spirometry or Peak expiratory flow measurement (For asthmatics)
C0037981 (UMLS CUI-1)
C0521299 (UMLS CUI-3)
FEV1
Item
FEV1 (age-appropriate standard value)
float
C0748133 (UMLS CUI [1])
FEV1
Item
FEV1
float
C0748133 (UMLS CUI [1])
Ratio; FEV1; standard value
Item
FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
integer
C0456603 (UMLS CUI [1])
C0588029 (UMLS CUI [2])
C1442989 (UMLS CUI [3])
Peak expiratory flow measurement
Item
PEF 1
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
PEF 2
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
PEF 3
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Best PEF
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
integer
C0521299 (UMLS CUI [1])
Item Group
Study medication and Concomitant medication (Taking back of the second study medication box with 7 blister pack)
C0013227 (UMLS CUI-1)
medication study
Item
Number of tablets left (study medication)
integer
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
medication Demand
Item
Number of tablets left (Loratadin)
integer
C0013227 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
details
Item
Mention, if incomplete
text
C1522508 (UMLS CUI [1])
medication
Item
Handing out of third study medication box with 8 blister pack and 1 blister pack of concomitant medication (if necessary)
boolean
C0013227 (UMLS CUI [1])
Item Group
Conjunctival provocation testing
C0430565 (UMLS CUI-1)
Item
Conjunctival provocation test result 1
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 1
CL Item
positive (1)
CL Item
negative (2)
Item
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
CL Item
positive (1)
CL Item
negative (2)
Item
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
CL Item
positive (1)
CL Item
negative (2)
Item
Allergen concentration at which the test outcome is positive
text
C1446561 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
Code List
Allergen concentration at which the test outcome is positive
CL Item
100 SQ- E/ ml (1)
CL Item
1000 SQ-E/ ml (2)
CL Item
10000 SQ-E/ ml (3)
Conjunctival provocation testing
Item
The outcome for all tests is negative
boolean

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